- Email: [email protected]
Tightening UK health administration
After that, any exemption will be assessed . makers register the new CFC-free prodregularly, but all waivers will end by the ucts, acknowledges that it could be diffi: cult to find effective alternatives and year 2000. The EU’s Committee for Proprietary pinpoints "the imminent lack of availabiliMedicinal Products has advised manufac: ty"of replacement propellants. turers to ensure that replacement proApplications to register reformulated pellant formulations also respect environproducts need to contain data proving mental considerations-the proposed that the new and the old products are at CFC alternatives are greenhouse gases, soleast therapeutically equivalent. Details of . their use could contribute to another envi- any new containers or valves used in the ronmental nasty global warming. Fromreformulated product are also needed. next year some applications for marketing CPMP warns that the CFC-to-alterauthorisation will have to include an envi- native switch raises potential safety conronmental risk assessment. Moreover, acems both from the new propellants CPMP guideline, which aims to help drug: themselves and from possible interactions
with the active drug substances. Changes in drug deposition patterns within the lung might also affect absorption and systemic safety. The guideline says clinical safety in man will be necessary. It goes on to recommend that the new non-CFCcontaining product should be compared with the licensed CFC-containing product over a three-month period. Drug makers should also assess the effects on the patients of the changeover from one product to another.
in a process set out by the government last year. The final "court of appeal" in this process would be a formal . review of the complaint by the chairman of the health authority or trust involved. : The health service ombudsman presently acts in response to patients’ complaints. The select committee thinks that the ombudsman should also deal with staff complaints. They envisage a system in which complaints from NHS staff concerning maladministration would be made to the select committee, who would then consider the case for referral to the : ombudsman. If these recommendations are taken up by the government, health-service staff will have gained the right of external appeal over serious concerns about administration.
in developed transfusion services elsewhere and reflected the limited knowledge available at the time, a point also made by The Lancet 1993; 342: 1887; that these doctors had been "tried by the media"; and that such severe sentences for actions based on best available knowledge could hamper medical progress by deterring people from working at the frontiers of medicine. The 1400 letters sent just before Christmas to the President, with copies to the Ministers of Health and Justice, had been circulated by Dr Marcella Contreras of the North London Blood Transfusion Service to colleagues around the world and to some blood donors. Another 1000 are waiting to be forwarded to the President. Dr M F Perutz, a Nobel laureate in chemistry and a founder of the MRC Laboratory of Molecular Biology at Cambridge, organised the letters from the Nobel laureates in medicine and chemistry and other distinguished people. And Dr F Barre-Sinoussi and Dr Jean Claude Gluckman from the department of virology at the Pasteur Institute in Paris had practically a complete response to the letter they sent to colleagues at the institute and others in related specialties around the world. Allain’s colleagues at the University of Cambridge, where he remains professor of transfusion medicine, have been taking other steps to clear his name. They have secured corrections to an article about him in the New Yorker, and in an interview with VSD, a widely circulated journal in France, have given an account of Allain’s actions during 1983-85. A point emphasised was how Allain had urged that heat-treated blood products be used and that if scientists were to fear imprisonment when their advice was not heeded, medical progress could stop. The university is also investigating the possibility of referring the case to the European Court of Human Rights. Meanwhile Allain is said to be in good heart and to have noticed a change in his treatment by other inmates and by prison officers practically immediately after publication of the VSD feature.
The
Tightening UK
health
administration Two very different documents were pub: lished this week; both aim to tackle: administrative problems in the national health service. In the first, Health Secretary Virginia Bottomley has set higher: standards of conduct and accountability for those in top management positions in the NHS. The new rules, contained in a consultation document, were drafted in the wake of a series of management irreg- : ularities (see Lancet 1993, Dec 18-25,: p 1416). In one case, a number of blun- : ders caused L10 million of health-service funds to be wasted in England’s West Midlands region. In the consultation document, the requirement that chairman and members of NHS boards should declare any conflict . of interest that arises as a consequence of involvement in NHS business is reiterated. Private interests that are relevant to NHS business, such as connection with an organisation contracting for NHS services, must now be formally recorded in the board’s minutes, and be included in the annual report. Public documents issued by the boards "should be clear, comprehensive and balanced, and should fully represent the facts". However, no move will be made to restrict earnings of chief executives. This inaction is despite controversy at the end of last year over the release of data that showed a median increase in remuneration for chief executives of 8-9% over the year ending March, 1993. : The new arrangements should be in . force by April 1, this year. The health secretary has also asked the NHS management executive "to consider urgently how best to ensure appropriate expenditure on management costs and executive remuneration in the NHS". : The other document published this week that is pertinent to administrators was the parliamentary select committee’s first report on the role of the ombudsman. At present, an NHS member of staff who is concerned about apparent maladministration would have their complaint investi-
228
gated locally
;
Sarah
Ramsay
Mitterand’s
mailbag
President Mitterand is receiving more lettes than usual these days. A few weeks ago there was a batch of 1400 letters, nearly 1200 of them from doctors and scientists working in blood transfusion. Then there have been those sent individually by about 25 Nobel laureates plus some past and present presidents of the royal medical colleges. And this week there was another batch of about 100 from another : group of doctors and scientists. This collective urge to write to the President of France represents the response to three invitations to sign open letters expressing the concern and sense of injustice felt over the judgment and prison sentences passed on Dr Michel Garretta and Prof Jean-Pierre Allain, two of the four doctors tried in connection with the large number of cases of HIV associated with transfusion of infected blood in the mid1980s (see Lancet 1992; 340: 1087). They had been judged to have done insufficient to prevent the circulation of HIV-infected blood products in 1984-85. Their supporters argue that the decisions made by these doctors were similar to those made
Sara Lewis
Vivien Choo
with the active drug substances. Changes in drug deposition patterns within the lung might also affect absorption and systemic safety. The guideline says clinical safety in man will be necessary. It goes on to recommend that the new non-CFCcontaining product should be compared with the licensed CFC-containing product over a three-month period. Drug makers should also assess the effects on the patients of the changeover from one product to another.
in a process set out by the government last year. The final "court of appeal" in this process would be a formal . review of the complaint by the chairman of the health authority or trust involved. : The health service ombudsman presently acts in response to patients’ complaints. The select committee thinks that the ombudsman should also deal with staff complaints. They envisage a system in which complaints from NHS staff concerning maladministration would be made to the select committee, who would then consider the case for referral to the : ombudsman. If these recommendations are taken up by the government, health-service staff will have gained the right of external appeal over serious concerns about administration.
in developed transfusion services elsewhere and reflected the limited knowledge available at the time, a point also made by The Lancet 1993; 342: 1887; that these doctors had been "tried by the media"; and that such severe sentences for actions based on best available knowledge could hamper medical progress by deterring people from working at the frontiers of medicine. The 1400 letters sent just before Christmas to the President, with copies to the Ministers of Health and Justice, had been circulated by Dr Marcella Contreras of the North London Blood Transfusion Service to colleagues around the world and to some blood donors. Another 1000 are waiting to be forwarded to the President. Dr M F Perutz, a Nobel laureate in chemistry and a founder of the MRC Laboratory of Molecular Biology at Cambridge, organised the letters from the Nobel laureates in medicine and chemistry and other distinguished people. And Dr F Barre-Sinoussi and Dr Jean Claude Gluckman from the department of virology at the Pasteur Institute in Paris had practically a complete response to the letter they sent to colleagues at the institute and others in related specialties around the world. Allain’s colleagues at the University of Cambridge, where he remains professor of transfusion medicine, have been taking other steps to clear his name. They have secured corrections to an article about him in the New Yorker, and in an interview with VSD, a widely circulated journal in France, have given an account of Allain’s actions during 1983-85. A point emphasised was how Allain had urged that heat-treated blood products be used and that if scientists were to fear imprisonment when their advice was not heeded, medical progress could stop. The university is also investigating the possibility of referring the case to the European Court of Human Rights. Meanwhile Allain is said to be in good heart and to have noticed a change in his treatment by other inmates and by prison officers practically immediately after publication of the VSD feature.
The
Tightening UK
health
administration Two very different documents were pub: lished this week; both aim to tackle: administrative problems in the national health service. In the first, Health Secretary Virginia Bottomley has set higher: standards of conduct and accountability for those in top management positions in the NHS. The new rules, contained in a consultation document, were drafted in the wake of a series of management irreg- : ularities (see Lancet 1993, Dec 18-25,: p 1416). In one case, a number of blun- : ders caused L10 million of health-service funds to be wasted in England’s West Midlands region. In the consultation document, the requirement that chairman and members of NHS boards should declare any conflict . of interest that arises as a consequence of involvement in NHS business is reiterated. Private interests that are relevant to NHS business, such as connection with an organisation contracting for NHS services, must now be formally recorded in the board’s minutes, and be included in the annual report. Public documents issued by the boards "should be clear, comprehensive and balanced, and should fully represent the facts". However, no move will be made to restrict earnings of chief executives. This inaction is despite controversy at the end of last year over the release of data that showed a median increase in remuneration for chief executives of 8-9% over the year ending March, 1993. : The new arrangements should be in . force by April 1, this year. The health secretary has also asked the NHS management executive "to consider urgently how best to ensure appropriate expenditure on management costs and executive remuneration in the NHS". : The other document published this week that is pertinent to administrators was the parliamentary select committee’s first report on the role of the ombudsman. At present, an NHS member of staff who is concerned about apparent maladministration would have their complaint investi-
228
gated locally
;
Sarah
Ramsay
Mitterand’s
mailbag
President Mitterand is receiving more lettes than usual these days. A few weeks ago there was a batch of 1400 letters, nearly 1200 of them from doctors and scientists working in blood transfusion. Then there have been those sent individually by about 25 Nobel laureates plus some past and present presidents of the royal medical colleges. And this week there was another batch of about 100 from another : group of doctors and scientists. This collective urge to write to the President of France represents the response to three invitations to sign open letters expressing the concern and sense of injustice felt over the judgment and prison sentences passed on Dr Michel Garretta and Prof Jean-Pierre Allain, two of the four doctors tried in connection with the large number of cases of HIV associated with transfusion of infected blood in the mid1980s (see Lancet 1992; 340: 1087). They had been judged to have done insufficient to prevent the circulation of HIV-infected blood products in 1984-85. Their supporters argue that the decisions made by these doctors were similar to those made
Sara Lewis
Vivien Choo